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Graft Versus Host Disease (GVHD)

Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone (BMT CTN 1705)
NCT04167514 | Phase 3 | Interventional

Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD

Trial Information
25 Sites
136 Participants
12 Years

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Stanford University
Stanford,California,United States,94305
University of Florida
Gainesville,Florida,United States,32608
Moffitt Cancer Center
Tampa,Florida,United States,33612
Emory University
Atlanta,Georgia,United States,30322-1059
Northside Hospital
Atlanta,Georgia,United States,30342
IU Hospital
Indianapolis,Indiana,United States,46202
Univ. of Kansas Cancer Center
Westwood,Kansas,United States,66205
Johns Hopkins Hospital
Baltimore,Maryland,United States,21287
Dana Farber Cancer Institute
Boston,Massachusetts,United States,02215
UM Medical Center
Ann Arbor,Michigan,United States,48109-0312
Karmanos Cancer Center
Detroit,Michigan,United States,48201
University of Minnesota
Minneapolis,Minnesota,United States,55455
Washington University
Saint Louis,Missouri,United States,63110
New York,New York,United States,10065
Levine Cancer Center
Charlotte,North Carolina,United States,28204
Durham,North Carolina,United States,27705
Cleveland Clinic
Cleveland,Ohio,United States,44124
Ohio State Univ.Medical Center
Columbus,Ohio,United States,43210
VanderbiltIngram Cancer Center
Nashville,Tennessee,United States,37232
Center for Gene Therapy
Houston,Texas,United States,77030
MD Anderson Cancer Center
Houston,Texas,United States,77030
Virginia Commonwealth Univ.
Richmond,Virginia,United States,23298
Fred Hutchinson Clinic
Seattle,Washington,United States,98109
University of Wisconsin
Madison,Wisconsin,United States,53705
Medical College of Wisconsin
Milwaukee,Wisconsin,United States,53226

Study Eligibility Criteria

  • Patients 12 years of age or older
  • Initial presentation of acute GVHD after allogeneic hematopoietic cell transplantation for any indication
  • Any graft or donor source or conditioning intensity
  • Clinical diagnosis of acute GVHD requiring systemic therapy with corticosteroids
  • Prior exogenous AAT exposure for GVHD prophylaxis
  • Relapsed, progressing, or persistent malignancy
  • de novo chronic GVHD or overlap syndrome developing before or present at the time of enrollment
  • Receiving other drugs for the treatment of GVHD
  • Receiving systemic CS for any indication within 7 days before the onset of acute GVHD

Additional Studies

Additional studies can be found at